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GMP COURSE

Course No 16902

GMP Auditor Workshop

5-6 September 2019, Berlin, Germany


Costs:
Non-ECA Members: EUR 1.790,--
ECA Members: EUR 1.590,--
EU GMP Inspectorates: EUR 895,--
APIC Members: EUR 1.690,--
(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers


Ágnes Kis, form. GMP Inspector at OGYÉI, Hungary
Christof Langer, OSConsulting, Austria
Thomas Højsholm Schmidt, Leo Pharma, Denmark
Kristina Smith Hansen, MilCor Consulting, Denmark
Miro Zdilar, Teva Pharmaceuticals, Croatia



Learning Objectives


In this Workshop you will have the possibility to learn and intensively discuss how to focus on specific GMP related aspects how to apply appropriate communication skills.

Background


Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified personal performing audits. And GMP audits of suppliers, contract manufacturers and contract laboratories are a fundamental part of a Quality Management System to assure the quality of a drug product. Only knowledgeable and highly qualified auditors with a profound technical knowledge and good communication skills can guarantee audits that are useful for both the auditing company and the auditee.

Recognising this need for further professional knowledge development, the ECA Academy has set up this workshop as an individual course which is also part of ECA’s Certified GMP Auditor Programme.

Target Group


This workshop is designed for both new and experienced auditors.

It can also be seen as an addition to the ECA Couse “The GMP Auditor”.

Programme


Kick-off: The Root Cause of poor personnel related Discrepancies
  • Introduction – humans are rational!
  • An explanation for undesirable behaviour
  • Utilising behaviour science models to change behaviour
  • A brief explanation on Nudging and Behavioural Design
How to audit Quality Systems
  • What should be included in a Quality System’s audit
  • Pitfalls when auditing Quality Systems
  • How to detect Quality System issues
How to audit Data Governance and Data Integrity
  • Examples of data governance and data integrity issues
  • Implications of data integrity issues
  • Auditors role in data integrity governance
  • Developing a data integrity audit program – “Hands-on Approach”
How to perform an API Site Audit
  • Chemical synthesis: Dedicated vs. multiple purpose facility, Material dispensing, Cross-Contamination, Process and cleaning validation, Utilities
  • Biotechnology: Cell banks, Inoculation, Fermentation, Harvest, Purification
How to deal with challenging Personalities in the Audit Room
  • Introduction: people are strange!
  • Top 10 most frustrating, difficult, or annoying personalities in an audit and how to deal with them
Parallel Sessions:

1) How to audit Production of solid Dosage Forms
  • Risk-based approach
  • Key points to consider
  • Exercise with role play
2) How to audit Production of sterile Dosage Forms
  • Key essentials and points to consider
  • Case studies
You will be able to attend one of these two parallel sessions. Please choose the one you like to attend when you register for the Course.

Parallel Sessions:

3) How to perform Quality Control Laboratory Audits
  • Sample receipt and registration
  • Sample preparation
  • Equipment Calibration and Maintenance
  • Reporting
4) How to audit Engineering and Technical Operations
  • HVAC systems
  • Water systems
  • Utilities: Pressured air, Clean steam, Special gases
  • Room qualification
  • Facility layouts
  • Flow of material and waste
You will be able to attend one of these two parallel sessions. Please choose the one you like to attend when you register for the Course.

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